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Augtyro Gets FDA Priority Review for NTRK-Positive Solid Cancers

The Food and Drug Administration will review Augtyro for potential approval in children and adults with advanced solid cancers that harbor NTRK gene fusions. ....

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EMA Validates MAA for Repotrectinib in ROS1+ NSCLC and NTRK+ Solid Tumors

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors. ....

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Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics. ....

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